(189 days)
The Audicor™ Sensor is a single-use, disposable medical device designed for short duration contact (up to 1 hour) for use at the V4 ECG electrode position to acquire both heart sounds and ECG electrical signals when attached to the body surface of a resting, adult (18+ years of age) patient, and to transmit these signals to compatible electrocardiographs and physiological recorders/monitors. Such equipment is commonly located in hospitals, doctor's offices and emergency vehicles.
The sensor is a single use, non-sterile, disposable medical device. When used with the Audicor Adaptor the device is designed to perform the functions of both a standard resting ECG Electrode by acquiring ECG signals and an Electronic Stethoscope by acquiring heart sounds from the surface of a patients skin. The device is intended for use on the surface of an adult patient's skin in the V4 electrode position on the chest.
The provided document describes the Inovise Medical, Inc. Audicor™ Sensor, an ECG Electrode & Heart Sound Transducer. The study conducted for this device is focused on showing its substantial equivalence to predicate devices and its compliance with specified performance standards and biocompatibility requirements.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Audicor™ Sensor seem to be its compliance with specific performance standards and biocompatibility requirements, as well as its functional similarity to predicate devices. The reported device performance is its successful compliance with these.
| Acceptance Criteria & Performance Standard | Reported Device Performance |
|---|---|
| AAMI EC12:2000 (Disposable ECG Electrodes) | The sensor was tested to the applicable requirements... and shown to comply. Laboratory and bench testing indicates compliance to the standard. |
| AAMI EC53:1995 (ECG Cables and Lead Wires) | The sensor was tested to the applicable requirements... and shown to comply. Laboratory and bench testing indicates compliance to the standard. |
| Biocompatibility (Hydrogel - primary patient contact material) | Evaluated for cytotoxicity, primary skin irritation, and delayed dermal contact sensitization. Test results demonstrate that the material was found acceptable. |
| Functional Equivalence (ECG Electrode Functionality) | Performs the functions of a standard resting ECG Electrode. Compared to Kendall Disposable ECG Electrode (K953649) and found to have "ECG Electrode Functionality: Yes". |
| Functional Equivalence (Heart Sound Acquisition) | Performs the functions of an Electronic Stethoscope by acquiring heart sounds. Compared to E-Scope Electronic Stethoscope (K961301) and found to "Acquires Heart Sounds: Yes" and "Uses Microphone: Yes". |
| General Performance and Safety | "Based on the results of the engineering/design level and biocompatibility tests, it is concluded that the sensor performs as expected and compares well, in terms of overall performance to the selected predicate devices and raises no new questions with regard to safety and efficacy." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for any test set or the data provenance (country of origin, retrospective/prospective). The study appears to be primarily focused on laboratory and bench testing of the device itself and biocompatibility testing of its hydrogel.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not mention the use of experts to establish ground truth for a test set in the context of diagnostic performance. The evaluation is against compliance with technical standards and biocompatibility, not clinical diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The study is about compliance with engineering standards and biocompatibility, not an assessment of diagnostic performance that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was mentioned. The device is a sensor, not an AI-powered diagnostic tool, and the study focuses on its physical and electrical performance and biocompatibility.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a sensor for acquiring physiological signals, not an algorithm. The "standalone" performance refers to the device's ability to meet the specified engineering and biocompatibility standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the defined parameters within the AAMI EC12:2000 and AAMI EC53:1995 standards for ECG electrodes and cables, respectively, and established methodologies for biocompatibility testing (cytotoxicity, primary skin irritation, and delayed dermal contact sensitization). It's essentially compliance with established industry and regulatory standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set. The study is an evaluation of hardware and material properties.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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Inovise Inc.
Attachment 3
AUG - 7 2003
Summary of Safety and Effectiveness As required by 21 CFR, part 807.92
| Submitted By: | Inovise Medical, Inc.1025 Industrial Parkway, Suite CNewberg, OR 97132Fax 503.538.8868 |
|---|---|
| Contact: | Kendra RathkeyTel 503.554.4277 |
| Date SummaryPrepared: | February 14, 2003 (revised June 24, 2003) |
| ProprietaryName: | Audicor™ Sensor |
| Common/UsualName: | ECG Electrode & Heart Sound Transducer. |
| Classification: | 21 CFR 870.2360 ECG Electrode, Class II, Product Code:DRX21 CFR 870.2860 Heart Sound Transducer, Class II, ProductCode: JOO |
| PerformanceStandards: | AAMI EC12:2000 (Disposable ECG Electrodes)AAMI EC53:1995 (ECG Cables and Lead Wires) |
| Intended Use: | The Audicor™ Sensor is a single-use, disposable medicaldevice designed for short duration contact (up to 1 hour) foruse at the V4 ECG electrode position to acquire both heartsounds and ECG electrical signals when attached to the bodysurface of a resting, adult (18+ years of age) patient, and totransmit these signals to compatible electrocardiographs andphysiological recorders/monitors. Such equipment iscommonly located in hospitals, doctor's offices andemergency vehicles. |
| DeviceDescription: | The sensor is a single use, non-sterile, disposable medicaldevice. When used with the Audicor Adaptor the device isdesigned to perform the functions of both a standard restingECG Electrode by acquiring ECG signals and an ElectronicStethoscope by acquiring heart sounds from the surface of apatients skin. The device is intended for use on the surface ofan adult patient's skin in the V4 electrode position on thechest. |
| Test Summary& Conclusion: | The sensor was tested to the applicable requirements of theperformance standards, identified above, and shown tocomply. Laboratory and bench testing indicates compliance |
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to the standard.
Biocompatibility for the hydrogel, the primary patient contact material of the sensor, was evaluated. Test results demonstrate that the material was found acceptable for cytotoxicity, primary skin irritation, and delayed dermal contact sensitization.
Based on the results of the engineering/design level and biocompatibility tests, it is concluded that the sensor performs as expected and compares well, in terms of overall performance to the selected predicate devices and raises no new questions with regard to safety and efficacy.
The Inovise Medical Audicor Sensor is substantially Substantial Equivalence: equivalent to the Kendall-LTP Disposable ECG electrode (K953649) and the E-Scope Electronic Stethoscope.
The table below contains the comparison of features and Technological principles of operation between the Audicor Sensor and other Characteristics: selected predicate devices.
| Feature | Inovise Medical, IncAudicor Sensor | KendallDisposable ECGElectrode | E-Scope ElectronicStethoscope |
|---|---|---|---|
| 510(k) Identifier | K030316 | K953649 | K961301 |
| Meets EC12-2000 Standard | Yes | Yes | No |
| Meets ISO 10993 Standard | Yes | Yes | Unknown |
| Disposable Device | Yes | Yes | No |
| Used on Patient Skin Surface | Yes | Yes | Yes |
| ECG Electrode Functionality | Yes | Yes | No |
| Used in V4 position | Yes | Yes | Yes and otherlocations |
| Uses Conductive Hydrogel | Yes | Yes | No |
| Primary Packaging | Paper/Poly/FoilPouch | Paper/Poly/FoilPouch | Durable device |
| Acquires Heart Sounds | Yes | No | Yes |
| Uses Microphone | Yes | No | Yes |
| Frequency Range | 20 – 660 Hz(nominal) | N/A | 10 - 2000 Hz |
| Operating Temperature | 10°C to 35 °C | Unknown | Unknown |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle. The eagle is facing to the right and has three stripes coming off of its head.
AUG - 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Inovise Medical, Inc. c/o Mr. John C. So Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, WA 98607
Re: K030316
Trade Name: Audicor™ COR Sensor Model M200 Regulation Number: 21 CFR 870.2360 and 21 CFR 870.1875 Regulation Name: Electrocardiograph Electrode and Stethoscope Regulatory Class: Class II (two) Product Code: DRX and DQD Dated: July 29, 2003 Received: July 30, 2003
Dear Mr. So:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - Mr. John C. So
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Inovise Inc.
Attachment 2
Indications for Use Statement
Applicant: Inovise Medical, Inc. K030316 510(k) Number (if known): Device Name: Audicor Sensor
Indications for use:
The Audicor™ Sensor is a single-use, disposable medical device designed for short duration contact (up to 1 hour) for use at the V4 ECG electrode position to acquire both heart sounds and ECG electrical signals when attached to the body surface of a resting, adult (18+ years of age) patient, and to transmit these signals to compatible electrocardiographs and physiological recorders/monitors. Such equipment is commonly located in hospitals, doctor's offices and emergency vehicles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109) ✓
Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030316
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.